Proposed Data Collection Submitted for Public Comment and Recommendations, 2362-2363 [2017-00080]
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Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
anticipated to cause adverse effects to
human health or adverse environmental
effects.’’ In contrast, EPCRA section
313(d)(2)(A) mandates that the EPA
consider whether ‘‘a chemical is known
to cause or can reasonably be
anticipated to cause significant adverse
acute human health effects at
concentration levels that are reasonably
likely to exist beyond facility site
boundaries.’’ The contrast demonstrates
that when Congress intends to
specifically require a risk assessment, it
does so. It decided not to do so in CAA
section 112(b)(3). The CAA is silent on
the issue of noncancer hazards and
quantitative cancer risk evaluation and
does not explicitly prohibit the EPA
from considering it when making a
determination under CAA section
112(b)(3)(B). As previously explained in
section II.C, the EPA also believes that
in meeting its obligation under CAA
section 112(b)(3)(B), the Administrator
has discretion in forming her decision to
either grant or deny a petition to add a
substance to the CAA section 112(b)(1)
HAP list. We believe this discretion
would allow her, where appropriate, to
consider risk evaluation of a substance
in order to make the requisite
determination as to whether a substance
is ‘‘known to cause or may reasonably
be anticipated to cause adverse effects to
human health or adverse environmental
effects,’’ under CAA section
112(b)(3)(B).
Thus, the EPA concludes that the
petitioners have met the CAA section
112(b)(3)(A) requisite showing of
adequate data by estimating nPB
emissions and ambient concentrations
that are likely to result beyond a
facility’s fence line and providing
adequate evidence of adverse health
effects of nPB. Because the EPA is
granting the petition for reasons stated
above, the agency does not find it
necessary to make determinations
regarding other elements of the petition,
such as a petitioner’s noncancer hazards
and quantitative cancer risk evaluation,
or whether nPB presents adverse
environmental effects.
V. EPA’s Decision To Grant the
Petitions
Based on the EPA’s evaluation of the
petitions submitted by HSIA and
NYSDEC, we conclude that the
petitioners have provided sufficient
information demonstrating the adverse
health effects of nPB. The documented
adverse health effects of nPB, which are
based on established sound scientific
principles, include carcinogenicity,
reproductive toxicity, and neurotoxicity.
The EPA also concludes that the
petitioner’s assessment regarding
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estimates of potential ambient
concentrations of nPB that are likely to
result at a facility’s fence line and
process emissions related information
and chemical usage information
representative of normal operating
conditions are reasonable. The EPA
concludes that there is adequate
evidence to support a determination
that nPB is an air pollutant and that
emissions and ambient concentrations
of nPB may reasonably be anticipated to
cause adverse effects to human health.
As mentioned above, we are seeking
comments on all aspects of this notice,
including EPA’s technical review of the
HSIA and NYSDEC petitions, whether
the criteria for listing have been met,
and the agency’s rationale for the
decision to grant these petitions.
VI. Statutory and Executive Order
Review
Additional information about this
Executive Order can be found at https://
www.epa.gov/laws-regulations/lawsand-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is a significant regulatory
action that was submitted to the Office
of Management and Budget (OMB) for
review because it raises novel legal or
policy issues. Any changes made in
response to OMB recommendations
have been documented in the docket.
Accordingly, the EPA is issuing this
draft notice announcing the decision to
grant petitions to add nPB to the CAA
section 112(b)(1) HAP list.
Dated: December 28, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2017–00158 Filed 1–6–17; 8:45 am]
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Dayna C. Brown,
Acting Secretary and Clerk of the
Commission.
[FR Doc. 2017–00321 Filed 1–5–17; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[60Day–17–17IY]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS)
ACTION: Notice with comment period;
withdrawal.
AGENCY:
The Agency for Toxic
Substances and Disease Registry
(ATSDR) in the Department of Health
and Human Services (HHS) announces
the withdrawal of the notice published
under the same title on December 30,
2016 for public comment.
DATES: Effective January 9, 2017.
FOR FURTHER INFORMATION CONTACT:
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: On
December 30, 2016 ATSDR published a
notice in the Federal Register titled
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ (Vol. 81, No. 251 FR
Doc. 2016–31738, Pages 96454–96456).
ATSDR prematurely and inadvertently
published this notice. The notice is
being withdrawn immediately for public
comment.
A new and corrected notice published
on January 3, 2017 under the same title
SUMMARY:
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09JAN1
Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices
(Vol. 82, No. 1 FR Doc. 2016–31772,
Pages 124–126, Docket No. ATSDR–
2016–0007) for public comment.
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–00080 Filed 1–6–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–6059–N6]
Medicare, Medicaid, and Children’s
Health Insurance Programs:
Announcement of the Extension of
Temporary Moratoria on Enrollment of
Part B Non-Emergency Ground
Ambulance Suppliers and Home Health
Agencies in Designated Geographic
Locations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Extension of temporary
moratoria.
AGENCY:
This document announces the
extension of statewide temporary
moratoria on the enrollment of new
Medicare Part B non-emergency ground
ambulance providers and suppliers and
Medicare home health agencies,
subunits, and branch locations in
Florida, Illinois, Michigan, Texas,
Pennsylvania, and New Jersey, as
applicable, to prevent and combat fraud,
waste, and abuse. This extension also
applies to the enrollment of new nonemergency ground ambulance suppliers
and home health agencies, subunits, and
branch locations in Medicaid and the
Children’s Health Insurance Program in
those states.
DATES: Effective January 29, 2017.
FOR FURTHER INFORMATION CONTACT:
Steve Manning, (410) 786–1691.
News media representatives must
contact CMS’ Public Affairs Office at
(202) 690–6145 or email them at press@
cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
I. Background
A. CMS’ Implementation of Temporary
Enrollment Moratoria
Under the Patient Protection and
Affordable Care Act (Pub. L. 111–148),
as amended by the Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–152) (collectively known as
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the Affordable Care Act), the Congress
provided the Secretary with new tools
and resources to combat fraud, waste,
and abuse in Medicare, Medicaid, and
the Children’s Health Insurance
Program (CHIP). Section 6401(a) of the
Affordable Care Act added a new
section 1866(j)(7) to the Social Security
Act (the Act) to provide the Secretary
with authority to impose a temporary
moratorium on the enrollment of new
Medicare, Medicaid or CHIP providers
and suppliers, including categories of
providers and suppliers, if the Secretary
determines a moratorium is necessary to
prevent or combat fraud, waste, or abuse
under these programs. Section 6401(b)
of the Affordable Care Act added
specific moratorium language applicable
to Medicaid at section 1902(kk)(4) of the
Act, requiring States to comply with any
moratorium imposed by the Secretary
unless the State determines that the
imposition of such moratorium would
adversely impact Medicaid
beneficiaries’ access to care. Section
6401(c) of the Affordable Care Act
amended section 2107(e)(1) of the Act to
provide that all of the Medicaid
provisions in sections 1902(a)(77) and
1902(kk) are also applicable to CHIP.
In the February 2, 2011 Federal
Register (76 FR 5862), CMS published a
final rule with comment period titled,
‘‘Medicare, Medicaid, and Children’s
Health Insurance Programs; Additional
Screening Requirements, Application
Fees, Temporary Enrollment Moratoria,
Payment Suspensions and Compliance
Plans for Providers and Suppliers,’’
which implemented section 1866(j)(7) of
the Act by establishing new regulations
at 42 CFR 424.570. Under
§ 424.570(a)(2)(i) and (iv), CMS, or CMS
in consultation with the Department of
Health and Human Services’ Office of
Inspector General (HHS–OIG) or the
Department of Justice (DOJ), or both,
may impose a temporary moratorium on
newly enrolling Medicare providers and
suppliers if CMS determines that there
is a significant potential for fraud,
waste, or abuse with respect to a
particular provider or supplier type, or
particular geographic locations, or both.
At § 424.570(a)(1)(ii), CMS stated that it
would announce any temporary
moratorium in a Federal Register
document that includes the rationale for
the imposition of such moratorium. This
document fulfills that requirement.
In accordance with section
1866(j)(7)(B) of the Act, there is no
judicial review under sections 1869 and
1878 of the Act, or otherwise, of the
decision to impose a temporary
enrollment moratorium. A provider or
supplier may use the existing appeal
procedures at 42 CFR part 498 to
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2363
administratively appeal a denial of
billing privileges based on the
imposition of a temporary moratorium;
however the scope of any such appeal
is limited solely to assessing whether
the temporary moratorium applies to the
provider or supplier appealing the
denial. Under § 424.570(c), CMS denies
the enrollment application of a provider
or supplier if the provider or supplier is
subject to a moratorium. If the provider
or supplier was required to pay an
application fee, the application fee will
be refunded if the application was
denied as a result of the imposition of
a temporary moratorium (see
§ 424.514(d)(2)(v)(C)).
Based on this authority and our
regulations at § 424.570, we initially
imposed moratoria to prevent
enrollment of new home health
agencies, subunits, and branch
locations 1 (hereafter referred to as
HHAs) in Miami-Dade County, Florida
and Cook County, Illinois, as well as
surrounding counties, and Medicare
Part B ground ambulance suppliers in
Harris County, Texas and surrounding
counties, in a notice issued on July 31,
2013 (78 FR 46339).2 We exercised this
authority again in a notice published on
February 4, 2014 (79 FR 6475) when we
extended the existing moratoria for an
additional 6 months and expanded them
to include enrollment of HHAs in
Broward County, Florida; Dallas
County, Texas; Harris County, Texas;
and Wayne County, Michigan and
surrounding counties, and enrollment of
ground ambulance suppliers in
Philadelphia, Pennsylvania and
surrounding counties. Then, we further
extended these moratoria in documents
issued on August 1, 2014 (79 FR 44702),
February 2, 2015 (80 FR 5551), July 28,
2015 (80 FR 44967), and February 2,
2016 (81 FR 5444). On August 3, 2016
(81 FR 51120), we extended the current
moratoria for an additional 6 months
and expanded them to statewide for the
1 As noted in the preamble to the final rule with
comment period implementing the moratorium
authority (February 2, 2011, CMS–6028–FC (76 FR
5870), home health agency subunits and branch
locations are subject to the moratoria to the same
extent as any other newly enrolling home health
agency.
2 CMS has identified an error in the provider and
beneficiary saturation data described in our July 31,
2013 Federal Register notice (78 FR 46339). We
have subsequently revised the methodology by
which we determine provider and beneficiary
saturation. Following these revisions to the
methodology, we simulated application of our
current 2016 methodology to the 2013 data, and
determined that the 2013 decision to impose the
moratorium would not have been impacted had the
revised methodology been applied. Provider
saturation remains one of the criteria used to
determine whether to implement a moratorium.
CMS has made market saturation data publicly
available at https://data.cms.gov/market-saturation.
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[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2362-2363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[60Day-17-17IY]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Department of Health and Human Services (HHS)
ACTION: Notice with comment period; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR)
in the Department of Health and Human Services (HHS) announces the
withdrawal of the notice published under the same title on December 30,
2016 for public comment.
DATES: Effective January 9, 2017.
FOR FURTHER INFORMATION CONTACT: Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: On December 30, 2016 ATSDR published a
notice in the Federal Register titled ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' (Vol. 81, No. 251 FR
Doc. 2016-31738, Pages 96454-96456). ATSDR prematurely and
inadvertently published this notice. The notice is being withdrawn
immediately for public comment.
A new and corrected notice published on January 3, 2017 under the
same title
[[Page 2363]]
(Vol. 82, No. 1 FR Doc. 2016-31772, Pages 124-126, Docket No. ATSDR-
2016-0007) for public comment.
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-00080 Filed 1-6-17; 8:45 am]
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